Cleared Traditional

K932889 - PERRY SPECIALTIES DESIGNS NEEDLE GUARD

K932889 is an FDA 510(k) clearance for PERRY SPECIALTIES DESIGNS NEEDLE GUARD, manufactured by Perry Specialties Design, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 1079-day FDA review.

K932889 · Perry Specialties Design, Inc. · General Hospital
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May 1996
Decision
1079d
Days
Class 2
Risk

K932889 is an FDA 510(k) clearance for the PERRY SPECIALTIES DESIGNS NEEDLE GUARD. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Perry Specialties Design, Inc. (Columbus, US). The FDA issued a Cleared decision on May 28, 1996 after a review of 1079 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Perry Specialties Design, Inc. devices

FDA 510(k) Submission Details - K932889

510(k) Number K932889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1993
Decision Date May 28, 1996
Days to Decision 1079 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
950d slower than avg
Panel avg: 129d · This submission: 1079d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 405
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K932889.
GE STERILE ARTHROGRAM TRAY
K962035 · GE Medical Systems · Jun 1996
RNS ARTHROGRAM TRAY
K962040 · Contour Fabricators of Florida, Inc. · Jun 1996
BEC SHROUDED PLASTIC CANNULA
K961328 · Biological & Environmental Control Laboratories · May 1996
RECAP-1
K960641 · Medscience, Inc. · May 1996
CORD WRAP WITH NEEDLE RESHEATHER
K960963 · Osborn Medical Corp. · May 1996
NON-CORING NEEDLE
K960698 · Med Institute, Inc. · Apr 1996